DINCON Consulting provides dedicated expert resources for quality, regulatory and compliance projects in the medical device industry.
Depending on the project scope, I can support clients directly as a senior consultant or coordinate additional subject-matter expertise through a professional network of specialists. This allows flexible support for short-term assignments, documentation reviews, remediation projects, audit preparation and larger compliance programs.
Dedicated resources may include support in the following areas:
- Quality Management System support according to ISO 13485
- EU MDR 2017/745 and FDA compliance
- Technical documentation and design dossier remediation
- Clinical Evaluation Reports, CER, PMS, PMCF and PSUR
- Risk Management according to ISO 14971
- Usability Engineering according to IEC 62366
- IEC 60601 and IEC 62304 documentation support
- UDI, labeling and ISO 15223 requirements
- Packaging validation according to ISO 11607
- Biocompatibility and ISO 10993 documentation support
- Cybersecurity and software-related regulatory documentation
- EU AI Act impact assessment in connection with MDR requirements
- Supplier qualification, supplier audits and purchasing controls
- CAPA, complaint handling, nonconformity management and audit preparation
I work with structured project planning, clear responsibilities, agreed deliverables and practical communication routines. My focus is to provide reliable, audit-ready and business-oriented support for Swiss, German and European medical device companies.